Effect of Gastric Balloon in Morbid Obesity: Prospective Study

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02128165

Enrollment

300

Registered

2014-05-01

Start date

2013-08-31

Completion date

2016-12-31

Last updated

2015-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity

Keywords

gastric balloon, morbid obesity

Brief summary

The aim of this study is to compare the efficacy of gastric balloon in weight reduction among two different categories of morbidly obese people.

Detailed description

To study to effect of gastric balloon in weight reduction among those above 35 BMI and those above 45 BMI.

Interventions

DEVICEBMI more than 45 BMI

Air filled gastric balloon (Heliosphere) those BMI above 45

DEVICEBMI less than 45 BMI

Air filled gastric balloon (Heliosphere) those BMI below 45

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

Inclusion criteria

* morbid obesity

Exclusion criteria

* patient refusal * psychological patients * oesophageal or gastric abnormalities

Design outcomes

Primary

Measure	Time frame	Description
Effect of weight loss	6 months	By following up the BMI every month

Secondary

Measure	Time frame	Description
Tolerance	6 months	Tolerance of patients to the balloon in form of vomiting, nausea, gastric pain

Countries

Egypt

Contacts

Primary Contactmohamed e abd ellatif, phd

0543973660

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026